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Abstract:

A composition is provided having nano technological delivery of a
medicament through the skin. The composition contains hydrocortisone,
resveratrol and a sulfate free surfactant. The composition is formulated
into a shampoo and the shampoo facilitates nano technological delivery of
the hydrocortisone and the resveratrol through the skin of a user.

Claims:

1. A shampoo composition for nano technological delivery of a medicament
in a topical base, the shampoo composition comprising: hydrocortisone; a
resveratrol composition of 1.00% resveratrol w/w in a carrier base
containing lecithin and glycerin, said resveratrol composition being
present in an amount of 0.01 to 1.00 percent w/w based on a total weight
of the shampoo composition; and a surfactant; wherein the composition
facilitates the nano technological delivery of said hydrocortisone and
said resveratrol through a scalp of a user.

2. The composition according to claim 1, wherein said hydrocortisone is
present in amount of about 0.01 to 1.00 percent w/w.

3. (canceled)

4. The composition according to claim 1, wherein said surfactant is a
sulfate free surfactant.

5. The composition according to claim 1, wherein said surfactant is
sodium lauroyl methyl isethionate.

6. The composition according to claim 1, further comprising sodium
lauroyl methyl isethionate in amount of 10 to 30 percent w/w.

7. The composition according to claim 1, wherein said hydrocortisone and
said resveratrol composition are present in a ratio in a range of
1:1-1:2.

8. The composition according to claim 1, wherein said hydrocortisone and
said resveratrol composition are present in a ratio in a range of
1:0.1-1:2.

9. The composition according to claim 1, wherein said hydrocortisone and
said resveratrol composition are present in a ratio in a range of
0.1:1-0.1:2.

11. The composition according to claim 1, wherein said hydrocortisone is
hydrocortisone acetate.

12. The composition according to claim 1, wherein said surfactant has a
sulfate.

13. A shampoo composition for delivery of a medicament in a shampoo base,
the composition comprising: hydrocortisone present in an amount 1% w/w
based by on a total weight of the shampoo composition; a carrier base
containing lecithin and glycerin present in an amount 0.1 to 1% w/w based
by on the total weight of the shampoo composition; and a surfactant;
wherein the composition being formulated as a shampoo composition and
whereby the composition facilitates a transdermal delivery of said
hydrocortisone through a scalp of a user.

14. (canceled)

15. The composition according to claim 13, wherein said hydrocortisone is
hydrocortisone acetate.

16. A method of delivering an active component through skin of a mammal,
which comprises the steps of: providing the composition according to
claim 1; applying the composition to the skin of the mammal; allowing the
composition to be absorbed by leaving the composition on the skin; and
using water to rinse the composition from the skin of the mammal.

17. The method according to claim 16, which further comprises leaving the
composition in place after the applying step for a period of time from
5-300 seconds.

18. The method according to claim 16, wherein the mammal is a human.

19. A shampoo composition for delivery of hydrocortisone in a carrier
base, the composition consisting essentially of: hydrocortisone in an
amount of 1% w/w based on a total weight of the shampoo composition; a
resveratrol composition of 1.00% resveratrol w/w in a carrier base
consisting of lecithin and glycerin, said resveratrol composition being
present in an amount of about 0.1 percent w/w based on the total weight
of said shampoo composition; and a surfactant; the composition
facilitating the nano technological delivery of said hydrocortisone and
said resveratrol through a scalp of a user.

20. The shampoo of claim 13 wherein said surfactant is a sulfate-free
surfactant.

Description:

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The skin surface of mammals is constructed to repel most molecules.
The skin acts as a barrier to protect the interior of a mammal. Topical
applications have been developed whereby various molecules are absorbed
through the skin. In addition to topical applications, transdermal drug
delivery has become an increasingly popular method for, among other
reasons, high levels of patient compliance. There still exists a
difficulty in transport of molecules through the various epidermal
membranes in order to effectuate drug absorption through the skin. One
method is to provide a carrier that assists in the transport of micron,
sub-micron and nano sized particles through the layers of the epidermis.
Safe and reproducible drug delivery can be achieved with deformable and
stable nano-sized carriers. The nano-sized carriers encompass materials
that to some degree deform the various pores in the skin allowing for the
transport of materials through and contrary to the skins natural barrier
configuration.

[0003] Although hydrocortisone products are known for topical use, they
typically are not used in shampoo formulations.

SUMMARY OF THE INVENTION

[0004] The present invention encompasses a composition, a method of
manufacture and a method of application of a nanotechnological delivery
of hydrocortisone and resveratrol in a topical preparation.

[0005] In one embodiment, the invention is a composition for the nano
technological delivery of a medicament in a shampoo base. The main
component is hydrocortisone. Hydrocortisone, as used herein, includes the
organic freebase, salts, isomers, and racemates. In one embodiment
hydrocortisone acetate is used. In one embodiment, the composition
contains hydrocortisone, resveratrol, and a surfactant. In one
embodiment, the composition contains hydrocortisone, and a sulfate free
surfactant. The composition is formulated into a shampoo and the shampoo
facilitates nano technological delivery of the hydrocortisone,
resveratrol, lecithin, and glycerin through the skin of a user.

[0006] The hydrocortisone is present in amounts of about 0.01 to 1.00
percent w/w and resveratrol is present in a resveratrol composition
wherein the composition is 1% w/w resveratrol in a carrier base of
glycerin and lecithin in an amount of approximately 0.01 to 1.00 percent
w/w. As used herein, the term "resveratrol composition" refers to a
composition containing 1% resveratrol in a carrier of lecithin and
glycerin. There is 0.01-1.00 percent w/w of the resveratrol composition
in the total formulation.

[0007] In one embodiment, the resveratrol composition of 1.00% resveratrol
w/w is in a carrier base consisting of lecithin and glycerin.

[0008] Additionally, the composition of the present invention is
formulated into a topical preparation as desired. The topical preparation
includes, but is not limited to the aforementioned shampoo, cream,
ointment, gel, lotion, and any other liquid, solution, suspension,
mixture, emulsion, semi-solid or the like.

[0009] One preferred surfactant is sodium lauroyl methyl isethionate and
the composition is formulated to contain approximately 10 to 30 percent
w/w.

[0010] The present invention has discovered that through a unique ratio of
hydrocortisone and resveratrol composition, the efficacy is enhanced.
Efficacy being defined as the absorption into the skin. In one embodiment
the hydrocortisone and resveratrol composition is present in a ratio of
about 1:1-1:2.

[0011] In another embodiment, the hydrocortisone and the resveratrol
composition are present in a ratio of about 1:0.1-1:2.

[0012] In another embodiment, the hydrocortisone and the resveratrol
composition are present in a ratio of about 0.1:1-0.1:2.

[0013] Also contemplated is a method of delivering an active component
through the skin of a mammal. The method utilizes a nanotechnological
delivery system containing the steps of: providing a composition
according to the present invention; applying the composition to the skin
of a mammal; and absorbing the composition. The absorbing includes
leaving the composition on the skin. Water is used to rinse the
composition from the skin of the mammal. In a preferred embodiment, the
method encompasses providing the composition formulated and presented to
a user as a shampoo. The shampoo is applied to the scalp, allowed to
remain, and rinsed.

[0014] The absorbing includes leaving the composition in place after the
applying step for a period of time from 5-300 seconds.

[0015] This method is further applicable to all skin surfaces and equally
applicable when the topical composition formulated with nanotechnological
delivery system of the present invention is formulated and presented as
cream, ointment, gel, lotion, foam, paste, and any other liquid mixture
such as aqueous mixture and/or aqueous-organic mixture, solution,
suspension, mixture, emulsion, semi-solid and the like.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0016] The invention encompasses a transdermal delivery of a combined
composition containing hydrocortisone and a resveratrol composition. Each
of the hydrocortisone and resveratrol composition is formulated utilizing
particular ratios that have been shown to have an advantageous
synergistic effect in effectuating trans-dermal drug delivery. In a
preferred embodiment, the present invention encompasses formulation of
hydrocortisone and resveratrol in a shampoo composition. The composition
includes a plurality of components to enhance the nanotechnological
delivery of the active components through the skin.

[0017] In one embodiment, the shampoo has a formulation as in Table 1
below.

[0018] In a preferred embodiment, when formulated as a shampoo, a base is
prepared starting with acrylate crosspolymer-4 in water. Although many
materials are suitable and known for shampoo formulation in general and
particularly for a formulation with a desired viscosity, the selected
acrylate crosspolymer-4 is selected based on the characteristics of
imparting a desired viscosity and compatibly with the nanotechnology
delivery components. This particular component in the above-stated range
is particular for compatibility for both the active materials of
hydrocortisone and resveratrol.

[0019] A preferred acrylate crosspolymer-4 is Carbopol aqua SF-2 polymer
(available from Lubrizol, Wickcliffe, Ohio). Additionally, the initial
base is prepared with panthenol, caffeine and tetrasodium EDTA. Once the
initial base is prepared and a solution is obtained, various components
selected with particularity and criticality as to percentage composition
and chemistry are added to the base.

[0021] Although it is well known in the art that there are numerous
surfactant bases suitable for shampoos in general and medical shampoos in
particular, it has been discovered in formulas of the present invention
that in order to deliver hydrocortisone and resveratrol utilizing a nano
technology delivery system a sulfate free surfactant needs to be
utilized. In a preferred embodiment the surfactant of the present
invention incorporates approximately 10 to 30 percent of sodium lauroyl
sarcocinate. A preferred material is available from RITA Corporation and
sold as RitaFactant LS-30. This material is selected with particularity
as to composition and to percentage used in the formulation of the
present invention in order to provide improved delivery of the active in
a nanotechnology delivery system.

[0022] In a preferred embodiment micronized hydrocortisone is utilized.
Hydrocortisone is present in a range of 0.1 to 1.0 percent w/w. The
particular micronization properties require a preferred material that has
a particle size of not less than 90 percent of the particles less than or
equal to five microns. Although, as stated herein, 90% is less than 5
microns, it is generally understood in the art that particle size
measurements are typically measured and presented as a Gaussian curve
with the major portion of the curve demonstrating particle size between
about 1 to 5 microns.

[0023] In a preferred embodiment, the shampoo is produced in a method as
now described.

[0024] Step 1

[0025] Add ingredients

[0026] Water,

[0027] Acrylates Crosspolymer-4,

[0028] Panthenol,

[0029] Caffeine, and

[0030] Tetrasodium EDTA--in order
in a suitable main kettle and mixed under propeller agitation.

[0031] Start heating ingredients to 78° C.-80° C.

[0032] Step 2

[0033] Once desired temperature is reached, add the following while
maintaining temperature and mixing.

[0034] Glycol Distearate,

[0035]
Cocamide DEA,

[0036] CocamidopropylBetaine,

[0037] Glycerin,

[0038]
Glycol Stearate,

[0039] Cocamide MEA,

[0040] Glycol Distearate,

[0041]
Sodium Lauroyl Methyl Isethionate,

[0042] Cholecalciferol,and

[0043] Zea
Mays (Corn) Oil.

[0044] Step 3

[0045] Once Steps 1-2 are at 78° C.-80° C., add, in order:

[0046] Sodium Lauroyl Sarcocinate,

[0047] Sodium C14-16 Olefin
Sulfonate,and

[0048] Potassium Cocoate.

[0049] Continue to mix until all ingredients are dissolved and maintain
temperature at 78° C.-80° C.

[0050] Step 4

[0051] When a uniform mixture is achieved, cool the batch to 70°
C.-75° C. When the batch is 70°-75° C., add:

[0054] When a uniform mixture is achieved, cool the mixture to 45°
C.-50° C.

[0055] Then add, while mixing--Polyquaternium-39.

[0056] Mix until uniform.

[0057] Step 6

[0058] When a uniform mixture is achieved, cool the mixture 40° C.
and add:

[0059] DMDM Hydantoin,

[0060] Methylchloroisothiazolinone, and

[0061] Methyl isothiazolinone.

[0062] Added in order under propeller agitation. Mix until uniform.

[0063] Step 7

[0064] In a second, or auxiliary vessel, premix the following ingredients
in advance under homogenizer agitation and mix until thoroughly
dispersed:

[0065] Propylene Glycol,

[0066] Hydrocortisone,

[0067]
Reservatrol,

[0068] Glycerin, and

[0069] Lecithin.

[0070] Add the mixture from the second vessel to the main vessel (Steps
1-6) where the main vessel is at 40° C. The adding of the
secondary vessel components are added to the main vessel under propeller
agitation.

[0071] Step 8

[0072] When the mixture of step 7 is uniform, cool the batch to 35°
C. and add:

[0073] Camellia Sinensis Leaf Extract (and) Water (and)
Glycerin,

[0074] Tocopheryl Acetate,

[0075] Magnesium Ascorbyl Phosphate,

[0076] RetinylPalmitate, and

[0077] Cholecalciferol (and) Zea Mays (Corn)
Oil.

[0078] The materials in step 8 are added under propeller agitation.

[0079] Step 9

[0080] In a third vessel, premix ingredients under propeller agitation and
mix until clear and uniform. The phase can optionally be warmed to
40° C. while mixing:

[0096] When the main product batch (Steps 1-8) is at 35° C., add
premixed step 9 mixture to main product batch under propeller agitation.
Mix until uniform.

[0097] Step 11

[0098] When the batch is uniform, add styrene/Acrylates Copolymer and mix
until uniform.

[0099] Step 12

[0100] When the batch is uniform, take the pH of the batch and use (Citric
Acid 50% Solution) to adjust the pH to 5.50-6.00.

[0101] Step 13

[0102] After the pH has been adjusted, take the viscosity of the batch.
Vicosity can be measured in any acceptable manner including Dynamic and
Kinematic measurements. A preferred measurement is using Brookfield RVT;
Spindle: 4; Speed: 20 rpm; Time: 1 Minute).

[0103] A NaCl solution is used as needed to adjust the viscosity to
3,500-5,000 cps. Each of pH and viscosity are measured between 25°
C. to 30° C. Care is taken, as it is known in the art that
viscosity of surfactant-based compositions is correlated to a salt
concentration gradient.

[0104] Step 14

[0105] When the viscosity is either in the desired range or has been
adjusted into the desired range, the composition is cooled to 30°
C. and discharge into suitable storage containers.

[0106] In one embodiment, the finished product exhibits the following
characteristics:

[0107] The present invention has discovered the enhanced nanotechnological
delivery of a hydrocortisone-resveratrol composition based on the
discovered base formulation and synergistic ratio of
hydrocortisone:resveratrol composition. The result will provide enhanced
absorption therapy over known compositions.

[0108] In one embodiment, the nanotechnolgical delivery system of the
present invention is prepared as any of a cream, lotion, ointment, or
gel. The cream will utilize the advantageous novel ratio of
hydrocortisone, resveratrol, lecithin, and glycerin to deliver the
actives in the novel nanotechnological delivery system discovered and
disclosed herein.

[0109] In one embodiment, it has further been discovered that
hydrocortisone formulated according to the present invention, while
omitting resveratrol maintains an acceptable level of efficacy for
delivery though the skin.

[0110] While the invention has been described in its preferred form or
embodiment with some degree of particularity, it is understood that this
description has been given only by way of example and that numerous
changes in the details of construction, fabrication, and use, including
the combination and arrangement of parts, may be made without departing
from the spirit and scope of the invention.

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